2026 · 3rd Quarter (July 1 - Sep 30)
Filed by TODD STRATEGY GROUP.
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Literal source text
General issues related to rare disease and orphan drugs. Policies related to international reference pricing for pharmaceuticals. Pharmaceutical supply chain manufacturing. Pharmaceutical pricing negotiations. H.R.3521/S.4440: Clinical Trials Modernization Act. H.R.5509/S.2903: Safe Step Act. H.R.946/S.1862: Optimizing Research Progress Hope and New Cures (ORPHAN Cures) Act.
Literal federal measure citations: H.R.3521, S.4440, H.R.5509, S.2903, H.R.946, S.1862
Issues related to the development of novel therapies including cell therapy and antibody drug conjugates (ADCs). Issues related to most-favored nations drug pricing proposals. FDA modernization policy. BIOSECURE Act implementation. Value-based payment arrangements.
CMMI GENEROUS Demo. Most Favored Nation (MFN). Implementation of the Inflation Reduction Act (IRA) including orphan drug exclusion. Issues related to the Medicare title in Public Law No. 119-21, formerly H.R.1,One Big Beautiful Bill Act (OBBBA). Issues relating to Medicare Parts B and D. Medicare Drug Price Negotiation Program. PBM Reform. 340B Rebate Model Pilot Program. H.R.9599: The SECURE 340B Act. Implementation of Public Law No. 119-21, formerly H.R.1,One Big Beautiful Bill Act (OBBBA).
Pharmaceutical tariffs.
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